Incidence and Predictors of Bleeding Diathesis Development Due to DIC in Cirrhosis and ACLF Patients Undergoing CRRT
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of dialysis related bleeding in first 24 hours
研究概览
简要总结
ACLF and cirrhotic patient have deranged coagulation parameters and this coagulation parameters altered when this group of patients undergoing dialysis because of renal failure. this group of patients is also high risk of sepsis. Most common organ involved during sepsis leading to organ failure is renal. So, all this cascade increases the risk of bleeding as well as coagulation failure. Currently there are no studies evaluation the coagulation status in patients with cirrhosis undergoing dialysis. Further there are no studies evaluating the utility of these global tests of coagulation as a guide to judicious blood transfusion in these patients to prevent bleeding. Further there are no studies comparing the two different modalities of assessment.
详细描述
METHODOLOGY Aim: The incidence and predictors of bleeding diathesis development due to DIC in cirrhosis and ACLF patients undergoing CRRT
Primary Objective:
Primary: Development of bleeding diathesis within 3 days [ e.g-bleeding/ooze from access sites, GI bleeding (blood in ryles tube, hematemesis's, melena, bleeding PR), bleed form ET tube site, bleed form nose/mouth or any other site]
Secondary Objective:
- Assess the following factors as predictors of bleeding diathesis within 3 days:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with cirrhosis or ACLF undergoing their first session of dialysis
排除标准
- •Age <12 or > 75 years
- •Hepatocellular Carcinoma
- •Recent history of blood product transfusion in the last 7 days
- •History of antiplatelets, antifibrinolytics or antithrombotics
- •Active untreated Sepsis/DIC
- •Any evidence of active bleed secondary to coagulopathy
- •Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease )
- •Refusal to participate in the study.
结局指标
主要结局
Incidence of dialysis related bleeding in first 24 hours
时间窗: 24 hours
次要结局
- To assess correlation of ROTEM abnormalities with risk of clinically significant bleeding(24 hours)
- To assess the volume of platelet pre- and post-procedure(24 hours)
- To assess the volume of FFP pre- and post-procedure(24 hours)
- To assess the volume of Cryoprecipitate pre- and post-procedure(24 hours)
- To assess the volume of packed red blood cell transfusion based on ROTEM pre- and post-procedure(24 hours)
- Incidence of transfusion associated lung injury and circulatory overload in both groups at 24 hours(24 hours)
- Mortality(7 days)
- Incidence of infections(7 days)
- Incidence of bleeding(7 days)
- Duration of Intensive Care Unit or hospital(7 days)